MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.6MM WIRE SLEEVE; GUIDE

Catalog Number	323.055
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: the orthokit technician reports that during the checking , they discovered that four new broaches guides were curved.The curve is visible to the naked eye and causes inconvenience when he had passed the broaches inside.This report is for one (1) 1.6mm wire sleeve.This is report 2 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: four centering sleeves f/kirschner wire ø 1.6mm were returned for evaluation.The visual inspection confirmed that the centering sleeves are slightly bent; furthermore, the devices are in good condition.Dimensional inspection checked dimensions with caliper per drawing the outer diameter of the sleeve shaft measures 2.73 - 2.74mm specification: 2.8mm (-0.04 /-0.07 mm) = pass.Document / specification review drawings and leaflet were reviewed during this investigation.These centering sleeves are slightly pre-bend for self-holding properties (deflection) function test for self-holding was performed per 100% at manufacturing with no issues noted the review of the manufacturing documents has shown that with 1.4301 (hard) stainless steel the correct material was used summary the complaint condition is unconfirmed as the returned centering sleeves comply with the specifications.The minimal shaft curvature is according to the specifications and is required for self-holding properties in the drill sleeve.This production lot (18p9619) was manufactured in november2019 according to the specification.Function test for self-holding was performed per 100% at manufacturing with no issues reported.The investigation found no manufacturing or product related issues.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part: 323.055, lot: 18p9619, manufacturing site: hägendorf, release to warehouse date:15.Nov.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.6MM WIRE SLEEVE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9581102
• Report Number: 8030965-2020-00281
• Device Sequence Number: 11533087
• Product Code: FZX
• UDI-Device Identifier: 07611819117549
• UDI-Public: (01)07611819117549
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 323.055
• Device Lot Number: 18P9619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1